Decreasing Depression and Anxiety and Their Effect on QoL of ESRD Patients (End-Stage Renal Disease)

NCT ID: NCT03330938

Last Updated: 2018-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2018-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study evaluates the effect of a single cognitive-behavioral intervention (CBI) in a control group against the same CBI plus the strengthening of resiliency skills in an experimental group, on ESRD patients.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Cognitive behavioral therapy has long been an alternative in the treatment of symptoms of depression and anxiety in patients with chronic diseases such as renal failure, however the combination of therapeutic approaches that include not only pathological but also another more positive approach (as the resilient model), represents a novel proposal for the treatment of negative psychological symptoms and improvement of the quality of life in these patients.

The inclusion of the resilient model in a cognitive behavioral intervention serves as a possibility of therapeutic target that could enhance the effectiveness of the treatment.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

End-Stage Renal Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, parallel, randomized clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
Evaluation measures

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CBI and Resilience

8 sessions total, once a week, 2 hours long each, consistent of 6 sessions of Cognitive-behavioral Intervention (CBI) plus 2 sessions to improve resilience strengths.

Group Type EXPERIMENTAL

CBI and Resilience

Intervention Type BEHAVIORAL

A combination of CBI techniques (Behavioural activation with positive reinforcement, Deep breathing and muscle relaxation, Cognitive restructuring) + Resilience strengthening (Identifying resilient strengths and potentialities, plus Imagination and projection into the future).

Cognitive-behavioral Intervention

8 sessions total, once a week, 2 hours long each. Cognitive-behavioral Intervention (CBI) without resilience strengthening.

Group Type ACTIVE_COMPARATOR

Cognitive-behavioral Intervention

Intervention Type BEHAVIORAL

Only CBI techniques (Behavioural activation with positive reinforcement, Deep breathing and muscle relaxation, Cognitive restructuring).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CBI and Resilience

A combination of CBI techniques (Behavioural activation with positive reinforcement, Deep breathing and muscle relaxation, Cognitive restructuring) + Resilience strengthening (Identifying resilient strengths and potentialities, plus Imagination and projection into the future).

Intervention Type BEHAVIORAL

Cognitive-behavioral Intervention

Only CBI techniques (Behavioural activation with positive reinforcement, Deep breathing and muscle relaxation, Cognitive restructuring).

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

CBI

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Older than 18, and younger than 61 years old
* Depression score in the Beck Depression Inventory (BDI) greater than 30 points.
* Anxiety score in the Beck Anxiety Inventory (BAI) greater than 40 points.
* Have not been hospitalized over the last 6 months
* Signing of informed consent

Exclusion Criteria

* May not be able to communicate in the Spanish language.
* Presence of psychiatric comorbidity (suicide ideation or depressive or anxious).
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Guadalajara

OTHER

Sponsor Role collaborator

Hospital Civil de Guadalajara

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Cristina Jazmin Gonzalez Flores

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rosa Martha Meda, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Guadalajara

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cristina Jazmín Gonzalez Flores

Guadalajara, Jalisco, Mexico

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Mexico

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Cristina González, Master

Role: CONTACT

3310411636

Rosa Martha Meda, PhD

Role: CONTACT

3310411636

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Guillermo García, PhD

Role: primary

3310411636

References

Explore related publications, articles, or registry entries linked to this study.

Chan L, Tummalapalli SL, Ferrandino R, Poojary P, Saha A, Chauhan K, Nadkarni GN. The Effect of Depression in Chronic Hemodialysis Patients on Inpatient Hospitalization Outcomes. Blood Purif. 2017;43(1-3):226-234. doi: 10.1159/000452750. Epub 2017 Jan 24.

Reference Type BACKGROUND
PMID: 28114133 (View on PubMed)

Chan R, Dear BF, Titov N, Chow J, Suranyi M. Examining internet-delivered cognitive behaviour therapy for patients with chronic kidney disease on haemodialysis: A feasibility open trial. J Psychosom Res. 2016 Oct;89:78-84. doi: 10.1016/j.jpsychores.2016.08.012. Epub 2016 Aug 29.

Reference Type BACKGROUND
PMID: 27663114 (View on PubMed)

Duarte PS, Miyazaki MC, Blay SL, Sesso R. Cognitive-behavioral group therapy is an effective treatment for major depression in hemodialysis patients. Kidney Int. 2009 Aug;76(4):414-21. doi: 10.1038/ki.2009.156. Epub 2009 May 20.

Reference Type BACKGROUND
PMID: 19455196 (View on PubMed)

Wang JL, Zhang DJ, Zimmerman MA. RESILIENCE THEORY AND ITS IMPLICATIONS FOR CHINESE ADOLESCENTS. Psychol Rep. 2015 Oct;117(2):354-75. doi: 10.2466/16.17.PR0.117c21z8. Epub 2015 Oct 7.

Reference Type BACKGROUND
PMID: 26444835 (View on PubMed)

John MM, Gupta A, Sharma RK, Kaul A. Impact of residual renal function on clinical outcome and quality of life in patients on peritoneal dialysis. Saudi J Kidney Dis Transpl. 2017 Jan-Feb;28(1):30-35. doi: 10.4103/1319-2442.198109.

Reference Type BACKGROUND
PMID: 28098100 (View on PubMed)

Lerma A, Perez-Grovas H, Bermudez L, Peralta-Pedrero ML, Robles-Garcia R, Lerma C. Brief cognitive behavioural intervention for depression and anxiety symptoms improves quality of life in chronic haemodialysis patients. Psychol Psychother. 2017 Mar;90(1):105-123. doi: 10.1111/papt.12098. Epub 2016 Jul 20.

Reference Type BACKGROUND
PMID: 27435635 (View on PubMed)

Matzka M, Mayer H, Kock-Hodi S, Moses-Passini C, Dubey C, Jahn P, Schneeweiss S, Eicher M. Relationship between Resilience, Psychological Distress and Physical Activity in Cancer Patients: A Cross-Sectional Observation Study. PLoS One. 2016 Apr 28;11(4):e0154496. doi: 10.1371/journal.pone.0154496. eCollection 2016.

Reference Type BACKGROUND
PMID: 27124466 (View on PubMed)

Zalai D, Szeifert L, Novak M. Psychological distress and depression in patients with chronic kidney disease. Semin Dial. 2012 Jul;25(4):428-38. doi: 10.1111/j.1525-139X.2012.01100.x.

Reference Type BACKGROUND
PMID: 22809005 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

p3wkkbgz

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Bounce-Back From Depression
NCT06832605 NOT_YET_RECRUITING NA